GSK Braces For Impact: Advair Generic Could Reduce US Brand To £1Bn
Although it’s not yet clear if an interchangeable version of the respiratory blockbuster will be approved by FDA, CEO Andrew Witty prepared investors to expect a hit, forecasting that a mid-year launch could significantly reduce revenues.
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GlaxoSmithKline is poised for a challenging 2018, with an interchangeable Advair generic expected to launch, but GSK believes growth from new products will make up some of the loss. US Advair sales could be slashed to £750m from £1.6bn in 2017.
Top-line data from a second patient group, asthmatics, in the Salford Lung Study indicate that switching from usual therapy to GSK’s’s Relvar Ellipta improves symptoms, but the results may not be enough to encourage switching before generic Seretide/Advair takes hold.
Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.